make sure that [100,000:<100,000 copies/mL. 201 Emtricitabine/rilpivirine/tenofovir alafenamide fixed combination (Odefsey ) can be used alone as a complete treatment regimen in antiretroviral-naive adults and adolescents ≥12 years of age weighing ≥35 kg with baseline plasma HIV-1 RNA levels 100,000 copies/mL; 244 also can be used to replace a stable antiretroviral regimen in antiretroviral-experienced patients who are virologically suppressed (i.e., plasma HIV-1 RNA levels> <50 copies/mL) on their current regimen for ≥6 months, have no history of treatment failure, and are infected with HIV-1 with no known substitutions associated with resistance to the components of the fixed combination. 244 Emtricitabine/rilpivirine/tenofovir DF fixed combination (Complera ) can be used alone as a complete treatment regimen in antiretroviral-naive adults and adolescents ≥12 years of age weighing ≥35 kg with baseline plasma HIV-1 RNA levels 100,000 copies/mL; 233 also can be used to replace a stable antiretroviral regimen in antiretroviral-experienced patients who are virologically suppressed (i.e., plasma HIV-1 RNA levels> <50 copies/mL) on their current regimen for ≥6 months, are currently receiving only their first or second antiretroviral regimen, have no history of treatment failure, and have no current evidence or history of resistance to the components of the fixed combination. 233 Consider that patients with baseline plasma HIV-1 RNA levels >100,000 copies/mL have had higher rates of virologic failure while receiving a rilpivirine regimen than those with lower baseline HIV-1 RNA levels. 1 233 Also consider that patients with baseline CD4 + T-cell counts> <200 cells/mm 3 (regardless of HIV-1 RNA levels) have had higher rates of virologic failure while receiving a rilpivirine regimen than those with higher baseline CD4 + T-cell count. 1 233 Patients experiencing virologic failure while receiving a rilpivirine regimen have had higher rates of overall treatment resistance and NNRTI-class cross-resistance than those receiving an efavirenz regimen. 1 In addition, resistance to lamivudine and emtricitabine) developed more frequently in patients receiving rilpivirine and these NRTIs than in patients receiving an efavirenz and these NRTIs. 1 Postexposure Prophylaxis following Occupational Exposure to HIV (PEP) Postexposure prophylaxis of HIV infection following occupational exposure † (PEP) in health-care personnel and others exposed via percutaneous injury (e.g., needlestick, cut with sharp object) or mucous membrane or nonintact skin (e.g., chapped, abraded, dermatitis) contact with blood, tissue, or other body fluids that might contain HIV. 199 Used in conjunction with other antiretrovirals. 199 USPHS recommends 3-drug regimen of raltegravir in conjunction with emtricitabine and tenofovir DF as the preferred regimen for PEP following occupational exposures to HIV. 199 Rilpivirine and 2 NRTIs is one of several alternative regimens. 199 Preferred dual NRTI option for use in PEP regimens is emtricitabine and tenofovir DF (may be given as emtricitabine/tenofovir DF; Truvada ); 199 alternative dual NRTIs are tenofovir DF and lamivudine, lamivudine and zidovudine (may be given as lamivudine/zidovudine; Combivir ), or zidovudine and emtricitabine. 199 Management of occupational exposures to HIV is complex and evolving; 199 consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or National Clinicians Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) whenever possible. 199 Do not delay initiation of PEP while waiting for expert consultation. 199 Postexposure Prophylaxis following Nonoccupational Exposure to HIV (nPEP) Postexposure prophylaxis of HIV infection following nonoccupational exposure † (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that might contain HIV when the exposure represents a substantial risk for HIV transmission. 198 Used in conjunction with other antiretrovirals. 198 When nPEP indicated in adults and adolescents ≥13 years of age with normal renal function, CDC states preferred regimen is either raltegravir or dolutegravir used in conjunction with emtricitabine and tenofovir DF (given as emtricitabine/tenofovir DF; Truvada ); 198 recommended alternative is ritonavir-boosted darunavir used in conjunction with emtricitabine/tenofovir DF (Truvada ). 198 Rilpivirine and 2 NRTIs (may be given as emtricitabine/rilpivirine/tenofovir DF; Complera ) is one of several other alternative regimens for nPEP. 198 Consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or the National Clinicians Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) if nPEP indicated in certain exposed individuals (e.g., pregnant women, children, those with medical conditions such as renal impairment) or if considering a regimen not included in CDC guidelines, source virus is known or likely to be resistant to antiretrovirals, or healthcare provider is inexperienced in prescribing antiretrovirals. 198 Do not delay initiation of nPEP while waiting for expert consultation. 198 Edurant Dosage and Administration Administration Oral Administration Rilpivirine (Edurant ): Administer orally once daily with a meal. 1 Use in conjunction with other antiretrovirals. 1 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Administer orally once daily with a meal. 244 Use alone as a complete treatment regimen. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Administer orally once daily with a meal. 233 Use alone as a complete treatment regimen. 233 Systemic exposure substantially decreased if rilpivirine given on empty stomach or with only a protein-rich nutritional drink. 1 Because antiretrovirals in the fixed combinations also may be available in single-entity or other fixed-combination preparations, take care to ensure that therapy is not duplicated if a fixed combination is used in conjunction with other antiretrovirals. 233 244 (See Precautions Related to Use of Fixed Combinations under Cautions.) Do not use single-entity rilpivirine (Edurant ) and emtricitabine/rilpivirine/tenofovir alafenamide concomitantly. 1 244 Do not use single-entity rilpivirine (Edurant ) and emtricitabine/rilpivirine/tenofovir DF (Complera ) concomitantly, unless needed for adjustment of rilpivirine dosage (e.g., when fixed combination used concomitantly with rifabutin). 1 233 Because of the tenofovir component, determine estimated CL cr , urine glucose, and urine protein prior to and monitor during treatment with emtricitabine/rilpivirine/tenofovir alafenamide or emtricitabine/rilpivirine/tenofovir DF in all patients. 233 244 In addition, monitor serum phosphorous in those with chronic kidney disease or at risk for renal impairment. 233 244 (See Renal Impairment under Cautions.) Dosage Available as rilpivirine hydrochloride; 1 dosage expressed in terms of rilpivirine. 1 Pediatric Patients Treatment of HIV Infection in Antiretroviral-naive Pediatric Patients Oral Rilpivirine (Edurant ) in adolescents ≥12 years of age weighing ≥35 kg: 25 mg once daily. 1 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily. 233 Treatment of HIV Infection in Antiretroviral-experienced Pediatric Patients Oral Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily. 233 Treatment of HIV Infection in Pediatric Patients Receiving Rifabutin Oral Rilpivirine (Edurant ) in adolescents ≥12 years of age weighing ≥35 kg: 50 mg once daily. 1 (See Specific Drugs under Interactions.) Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ) in adolescents ≥12 years of age weighing ≥35 kg: Concomitant use with rifabutin not recommended. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily and 25 mg of single-entity rilpivirine (Edurant ) once daily to provide total rilpivirine dosage of 50 mg daily. 233 (See Specific Drugs under Interactions.) Adults Treatment of HIV Infection in Antiretroviral-naive Adults Oral Rilpivirine (Edurant ): 25 mg once daily. 1 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily. 233 Treatment of HIV Infection in Antiretroviral-experienced Adults Oral Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily. 233 Treatment of HIV Infection in Adults Receiving Rifabutin Oral Rilpivirine (Edurant ): 50 mg once daily. 1 (See Specific Drugs under Interactions.) Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Concomitant use with rifabutin not recommended. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily and 25 mg of single-entity rilpivirine (Edurant ) once daily to provide total rilpivirine dosage of 50 mg daily. 233 (See Specific Drugs under Interactions.) Postexposure Prophylaxis following Occupational Exposure to HIV (PEP) † Oral Rilpivirine (Edurant ): 25 mg once daily. 199 Use in conjunction with 2 NRTIs (see Postexposure Prophylaxis following Occupational Exposure to HIV [PEP] under Uses). 199 Emtricitabine/rilpivirine/tenofovir DF (Complera ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily. 199 Use as a complete regimen for PEP. 199 Initiate PEP as soon as possible following occupational exposure to HIV (preferably within hours); 199 continue for 4 weeks, if tolerated. 199 Postexposure Prophylaxis following Nonoccupational Exposure to HIV (nPEP) † Oral Emtricitabine/rilpivirine/tenofovir DF (Complera ): 1 tablet (200 mg of emtricitabine, 25 mg of rilpivirine, and 300 mg of tenofovir DF) once daily. 198 Use as a complete regimen for nPEP. 198 Initiate nPEP as soon as possible (within 72 hours) following nonoccupational exposure that represents a substantial risk for HIV transmission and continue for 28 days. 198 nPep not recommended if exposed individual seeks care >72 hours after exposure. 198 Special Populations Hepatic Impairment Treatment of HIV Infection Rilpivirine (Edurant ): Use usual dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B); 1 not studied in those with severe hepatic impairment (Child-Pugh class C). 1 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Use usual dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B); 244 not studied in those with severe hepatic impairment (Child-Pugh class C). 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Use usual dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B); 233 not studied in those with severe hepatic impairment (Child-Pugh class C). 233 Renal Impairment Treatment of HIV Infection Rilpivirine (Edurant ): Use usual dosage in patients with mild or moderate renal impairment. 1 Manufacturer makes no specific dosage recommendations for those with severe renal impairment or end-stage renal disease (ESRD); 1 use with caution. 1 (See Renal Impairment under Cautions.) Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Use usual dosage in patients with estimated Cl cr ≥30 mL/minute; 244 not recommended in those with severe renal impairment (estimated Cl cr> <30 mL/minute). 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Do not use in those with moderate, severe, or end-stage renal impairment (estimated Cl cr> <50 mL/minute) or if dialysis required. 233 Geriatric Patients Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy. 1 233 Cautions for Edurant Contraindications Rilpivirine, emtricitabine/rilpivirine/tenofovir alafenamide, emtricitabine/rilpivirine/tenofovir DF: Concomitant use with drugs that induce CYP3A or elevate gastric pH contraindicated since substantially decreased plasma rilpivirine concentrations may occur and may result in loss of virologic response and development of resistance to rilpivirine and/or class resistance to other NNRTIs. 1 233 244 This includes certain anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), certain antimycobacterials (rifampin, rifapentine), systemic dexamethasone (given in multiple doses), proton-pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), and certain herbal supplements (St. John s wort [ Hypericum perforatum ]). 1 233 244 (See Interactions.) Emtricitabine/rilpivirine/tenofovir alafenamide, emtricitabine/rilpivirine/tenofovir DF: Consider contraindications associated with each drug in the fixed combination. 233 244 Warnings/Precautions Sensitivity Reactions Severe skin and hypersensitivity reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), reported during postmarketing experience. 1 233 244 Some skin reactions were accompanied by constitutional symptoms such as fever; 1 233 244 others were associated with organ dysfunction, including elevated hepatic enzyme serum concentrations. 1 233 244 Rash generally was grade 1 or 2 and occurred in the first 4 6 weeks of therapy. 1 233 244 Immediately discontinue rilpivirine, emtricitabine/rilpivirine/tenofovir alafenamide, or emtricitabine/rilpivirine/tenofovir DF if signs or symptoms of severe skin or hypersensitivity reactions develop (e.g., severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis, or eosinophilia). 1 233 244 Monitor clinical status, including laboratory parameters, and initiate appropriate therapy. 1 233 244 Interactions Concomitant use with certain drugs (e.g., drugs that may reduce rilpivirine concentrations, drugs known to increase risk of torsades de pointes) is contraindicated or requires particular caution. 1 233 244 (See Contraindications and see Interactions.) Depressive Disorders Depressive disorders (e.g., depressed mood, depression, dysphoria, major depression, altered mood, negative thoughts, suicide attempt, suicidal ideation) reported. 1 233 244 Depressive disorders reported in 9% of adults receiving rilpivirine in phase 3 clinical trials and in 19% of pediatric patients 12 to> <18 years of age receiving rilpivirine in phase 2 clinical trials. 1 233 244 Advise patients experiencing severe depressive symptoms to seek immediate medical evaluation to determine the likelihood that symptoms are related to rilpivirine and to determine if benefits of continued rilpivirine outweigh risks. 1 233 244 Hepatotoxicity Adverse hepatic effects reported; 1 233 244 hepatotoxicity reported in some patients without preexisting hepatic disease or other risk factors. 1 233 244 HIV-infected patients with HBV or HCV coinfection or marked elevations in aminotransferase concentrations prior to rilpivirine treatment may be at increased risk for development or worsening of aminotransferase concentration elevations. 1 233 244 In patients with underlying hepatic disease (e.g., HBV or HCV infection, elevated aminotransferase concentrations), perform laboratory tests to evaluate hepatic function prior to and during rilpivirine treatment (single entity or fixed combinations). 1 233 244 Consider liver enzyme monitoring in patients without preexisting hepatic disease or other risk factors. 1 233 244 Precautions Related to Use of Fixed Combinations Emtricitabine/rilpivirine/tenofovir alafenamide, emtricitabine/rilpivirine/tenofovir DF: Consider cautions, precautions, contraindications, and interactions associated with each drug in the fixed combination. 233 244 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug. 233 244 Because the antiretrovirals contained in the fixed combinations also may be available in single-entity or other fixed-combination preparations, take care to ensure that therapy is not duplicated if a fixed combination is used in conjunction with other antiretrovirals. 233 244 Do not use emtricitabine/rilpivirine/tenofovir DF concomitantly with single-entity rilpivirine, unless needed for adjustment of rilpivirine dosage (e.g., when fixed combination used concomitantly with rifabutin). 1 233 (See Specific Drugs under Interactions.) Because of similarities between emtricitabine and lamivudine, do not use fixed combinations containing emtricitabine concomitantly with any preparation containing lamivudine. 200 233 In addition, do not use fixed combinations containing tenofovir DF concomitantly with adefovir. 200 233 Adipogenic Effects Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement ( buffalo hump ), peripheral wasting, facial wasting, breast enlargement, and general cushingoid appearance. 1 233 244 Mechanisms and long-term consequences of adipogenic effects unknown; causal relationship not established. 1 233 244 Immune Reconstitution Syndrome During initial treatment, HIV-infected patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium , M. tuberculosis , cytomegalovirus [CMV], Pneumocystis jirovecii [formerly P. carinii ]); 1 233 244 this may necessitate further evaluation and treatment. 1 233 244 Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) also reported to occur in the setting of immune reconstitution; 1 233 244 time to onset is more variable and can occur many months after initiation of antiretroviral therapy. 1 233 244 Specific Populations Pregnancy Rilpivirine (Edurant ): Category B. 1 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Insufficient human data to assess risk of birth defects and miscarriage if used in pregnant women. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Category B. 233 Antiretroviral Pregnancy Registry at 800-258-4263 or . 1 202 233 244 Experts state rilpivirine in conjunction with tenofovir DF and emtricitabine (or rilpivirine in conjunction with a preferred 2-NRTI backbone) is an alternative NNRTI-based regimen for initial treatment of HIV-1 infection in pregnant women, but use only in patients with baseline plasma HIV-1 RNA levels> <100,000 copies/mL and baseline CD4 + T-cell count >200 cells/mm 3 . 202 Lactation Not known whether rilpivirine distributed into human milk; 1 distributed into milk in rats. 1 Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant. 1 202 233 244 Pediatric Use Rilpivirine (Edurant ): Safety, efficacy, and pharmacokinetics not established in pediatric patients> <12 years of age. 1 201 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Safety and efficacy not established in pediatric patients> <12 years of age or weighing> <35 kg. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Safety and efficacy not established in pediatric patients> <12 years of age or weighing> <35 kg. 233 Geriatric Use Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults. 1 233 244 Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy. 1 233 Hepatic Impairment Rilpivirine (Edurant ), emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ), emtricitabine/rilpivirine/tenofovir DF (Complera ): Not studied in patients with severe hepatic impairment (Child-Pugh class C). 1 233 244 (See Hepatic Impairment under Dosage and Administration.) Higher incidence of increased serum aminotransferase concentrations reported in HIV-infected patients coinfected with HBV and/or HCV compared with those without coinfection. 1 Renal Impairment Rilpivirine (Edurant ): Use with caution and increased monitoring for adverse effects in patients with severe renal impairment or ESRD; 1 increased rilpivirine concentrations possible due to alterations in absorption, distribution, or metabolism. 1 (See Renal Impairment under Dosage and Administration.) Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Not recommended in those with severe renal impairment (estimated Cl cr> <30 mL/minute). 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Do not use in those with moderate, severe, or end-stage renal impairment (estimated Cl cr> <50 mL/minute) or if dialysis required. 233 Common Adverse Effects Depressive disorders (see Depressive Disorders under Cautions), insomnia, headache, rash, increased serum AST and/or ALT concentrations (>2.5 times ULN). 1 Interactions for Edurant Rilpivirine is metabolized by CYP3A. 1 Tenofovir alafenamide, a component of emtricitabine/rilpivirine/tenofovir alafenamide, is a substrate of P-glycoprotein (P-gp) transport. 244 The following drug interactions are based on studies using rilpivirine, emtricitabine/rilpivirine/tenofovir alafenamide, emtricitabine/rilpivirine/tenofovir DF, or the individual components of fixed combinations, or are predicted to occur. 1 233 244 When a fixed combination used, consider interactions associated with each drug in the fixed combination. 233 244 Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes CYP3A inducers: Possible decreased rilpivirine concentrations and possible loss of virologic response and development of resistance to rilpivirine or the NNRTI class. 1 CYP3A inhibitors: Possible increased rilpivirine concentrations. 1 CYP substrates: Recommended rilpivirine dosage (25 mg once daily) unlikely to have clinically important pharmacokinetic interactions. 1 Drugs Affected by P-glycoprotein Transport P-gp inhibitors: If used with emtricitabine/rilpivirine/tenofovir alafenamide, possible increased absorption of tenofovir alafenamide; 244 may result in increased plasma concentrations of tenofovir alafenamide and increased adverse effects. 244 P-gp inducers: If used with emtricitabine/rilpivirine/tenofovir alafenamide, possible decreased absorption of tenofovir alafenamide; 244 may result in decreased plasma concentrations of tenofovir alafenamide leading to loss of therapeutic effect and development of resistance. 244 Drugs that Increase Gastric pH Possible decreased rilpivirine concentrations, loss of virologic response, and development of drug resistance or NNRTI-class resistance. 1 233 244 Drugs that Prolong the QT Interval Only limited data available to date regarding potential for pharmacodynamic interaction if used concomitantly with drugs known to prolong QT interval and increase the risk of torsades de pointes. 1 233 244 In healthy individuals, rilpivirine dosages of 75 or 300 mg daily (substantially higher than recommended dosage) resulted in clinically important prolongation of QT c interval. 1 233 244 Use caution if rilpivirine or emtricitabine/rilpivirine/tenofovir DF used concomitantly with drugs known to increase risk of torsades de pointes. 1 233 Consider alternative to emtricitabine/rilpivirine/tenofovir alafenamide in patients receiving drugs known to increase risk of torsades de pointes. 244 Nephrotoxic Drugs or Drugs Eliminated by Renal Excretion If used with emtricitabine/rilpivirine/tenofovir alafenamide or emtricitabine/rilpivirine/tenofovir DF: Potential increased concentrations of emtricitabine, tenofovir, and/or concomitant drug. 233 244 Specific Drugs Drug Interaction Comments Abacavir Pharmacokinetic interactions unlikely 1 No in vitro evidence of antagonistic antiretroviral effects 1 6 Acetaminophen No clinically important pharmacokinetic interactions 1 233 244 Dosage adjustments not needed 1 Acyclovir, valacyclovir If used with emtricitabine/rilpivirine/tenofovir alafenamide or emtricitabine/rilpivirine/tenofovir DF, possible increased concentrations of emtricitabine, tenofovir, and/or acyclovir and increased risk of adverse effects 233 244 Aminoglycosides (e.g., gentamicin) Gentamicin: If used with emtricitabine/rilpivirine/tenofovir alafenamide or emtricitabine/rilpivirine/tenofovir DF, possible increased concentrations of emtricitabine, tenofovir, and/or the aminoglycoside and increased risk of adverse effects 233 244 Antacids (aluminum hydroxide, calcium carbonate, magnesium hydroxide) Possible decreased rilpivirine concentrations with possible loss of virologic response and development of resistance 1 Use with caution; 1 233 244 take antacid at least 2 hours before or 4 hours after rilpivirine (single entity or fixed combinations) 1 233 244 Anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin) Possible decreased rilpivirine concentrations 1 Concomitant use with rilpivirine (single entity or fixed combinations) contraindicated 1 233 244 Antifungals, azoles Ketoconazole: Increased rilpivirine concentrations and AUC; 1 decreased ketoconazole concentrations and AUC 1 Fluconazole, isavuconazonium, itraconazole, posaconazole, voriconazole: Possible increased rilpivirine concentrations and decreased azole antifungal concentrations; 1 200 if used with emtricitabine/rilpivirine/tenofovir alafenamide, increased tenofovir alafenamide concentrations also possible 244 Dosage adjustments not needed if used with rilpivirine (single entity or fixed combinations); 1 200 233 244 monitor for breakthrough fungal infections 1 200 233 244 Antimycobacterials, rifamycins Rifabutin, rifampin, rifapentine: Decreased rilpivirine concentrations and AUC 1 200 Rifabutin: Increase single-entity rilpivirine dosage to 50 mg once daily; 1 if rifabutin is stopped, resume usual rilpivirine dosage (25 mg once daily); 1 if using emtricitabine/rilpivirine/tenofovir DF, use 1 tablet of fixed combination and a 25-mg tablet of single-entity rilpivirine once daily to provide total rilpivirine dosage of 50 mg daily; 233 concomitant use with emtricitabine/rilpivirine/tenofovir alafenamide not recommended 244 Rifampin, rifapentine: Concomitant use with rilpivirine (single entity or fixed combinations) contraindicated 1 233 244 Atazanavir Ritonavir-boosted , cobicistat-boosted , or unboosted atazanavir: Possible increased rilpivirine concentrations; 1 200 not expected to affect atazanavir concentrations 1 200 No in vitro evidence of antagonistic antiretroviral effects 1 6 Ritonavir-boosted , cobicistat-boosted , or unboosted atazanavir: Dosage adjustments not needed 200 Avanafil Data not available 200 Concomitant use not recommended 200 Benzodiazepines Alprazolam: Data not available 200 Lorazepam, midazolam: If used with emtricitabine/rilpivirine/tenofovir alafenamide, clinically important interactions not expected 244 Alprazolam: Monitor for alprazolam therapeutic effects 200 Buprenorphine Emtricitabine/rilpivirine/tenofovir alafenamide: Clinically important pharmacokinetic interactions not expected 244 Chlorzoxazone No clinically important pharmacokinetic interactions 1 233 244 Dosage adjustments not needed 1 Cidofovir If used with emtricitabine/rilpivirine/tenofovir alafenamide or emtricitabine/rilpivirine/tenofovir DF, possible increased concentrations of emtricitabine, tenofovir, and/or cidofovir and increased risk of adverse effects 233 244 Corticosteroids Systemic dexamethasone: Possible decreased rilpivirine concentrations if more than a single dose of dexamethasone used 1 Systemic dexamethasone: Concomitant use of more than a single dose of dexamethasone with rilpivirine (single-entity or fixed combinations) contraindicated 1 233 244 Daclatasvir Clinically important pharmacokinetic interactions not expected 178 Dosage adjustments not needed 200 Darunavir Ritonavir-boosted darunavir: Increased rilpivirine concentrations and AUC; 1 200 no clinically important effects on darunavir concentrations 1 200 Cobicistat-boosted darunavir: Possible increased rilpivirine concentrations 200 No in vitro evidence of antagonistic antiretroviral effects 1 6 Ritonavir-boosted or cobicistat-boosted darunavir: Dosage adjustments not needed 1 200 Delavirdine Possible increased rilpivirine concentrations 1 Concomitant use not recommended 1 200 Didanosine No effect on rilpivirine or didanosine concentrations when administered 2 hours apart 1 No in vitro evidence of antagonistic antiretroviral effects 1 6 Administer didanosine (without food) at least 2 hours before or 4 hours after rilpivirine (with food); 1 dosage adjustments not needed 1 Digoxin No clinically important effect on digoxin pharmacokinetics 1 233 244 Dolutegravir No clinically important effect on rilpivirine or dolutegravir pharmacokinetics 200 236 Dosage adjustments not needed 200 Efavirenz Possible decreased rilpivirine concentrations 1 No in vitro evidence of antagonistic antiretroviral effects 1 6 Concomitant use not recommended 1 200 Elbasvir and grazoprevir Fixed combination of elbasvir and grazoprevir (elbasvir/grazoprevir): No clinically important effect on elbasvir, grazoprevir, or rilpivirine pharmacokinetics 177 Elbasvir/grazoprevir: Dosage adjustments not needed 177 Elvitegravir Cobicistat-boosted elvitegravir: Possible altered elvitegravir, cobicistat, and/or rilpivirine concentrations 200 Elvitegravir in conjunction with ritonavir-boosted PI: Increased rilpivirine concentrations expected 200 Cobicistat-boosted elvitegravir: Do not use concomitantly 200 Elvitegravir in conjunction with ritonavir-boosted PI: Dosage adjustments not needed, but elvitegravir dosage depends on which ritonavir-boosted PI is used 200 Emtricitabine Pharmacokinetic interactions unlikely 1 No in vitro evidence of antagonistic antiretroviral effects 1 6 Enfuvirtide No in vitro evidence of antagonistic antiretroviral effects 1 6 Estrogens/progestins Contraceptives containing ethinyl estradiol and norethindrone: No clinically important pharmacokinetic interactions 1 233 244 Fixed combination of ethinyl estradiol and norgestimate: Clinically important pharmacokinetic interactions not expected with emtricitabine/rilpivirine/tenofovir alafenamide 244 Contraceptives containing ethinyl estradiol and norethindrone: Dosage adjustments not needed 1 Etravirine Possible decreased rilpivirine concentrations 1 No in vitro evidence of antagonistic antiretroviral effects 1 6 Concomitant use not recommended 1 200 Fosamprenavir Fosamprenavir or ritonavir-boosted fosamprenavir: Possible increased rilpivirine concentrations; 1 not expected to affect amprenavir concentrations (active metabolite of fosamprenavir) 1 No in vitro evidence of antagonistic antiretroviral effects with amprenavir (active metabolite of fosamprenavir) 1 6 Fosamprenavir (with or without low-dose ritonavir): Dosage adjustments not needed 200 Ganciclovir, valganciclovir If used with emtricitabine/rilpivirine/tenofovir alafenamide or emtricitabine/rilpivirine/tenofovir DF, possible increased concentrations of emtricitabine, tenofovir, and/or ganciclovir and increased risk of adverse effects 233 244 Histamine H 2 -receptor antagonists Famotidine: Decreased rilpivirine concentrations with possible loss of virologic response and development of resistance 1 Cimetidine, nizatidine, ranitidine: Possible decreased rilpivirine concentrations 1 Use with caution; 1 233 undercover agent
surgical treatment Edurant guidelines
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